Improving Sleep and Reducing External Stimuli With the Maya
Primary Purpose
Critical Illness
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Maya
Sponsored by
About this trial
This is an interventional other trial for Critical Illness
Eligibility Criteria
Inclusion Criteria:
- adult ICU, MC or CCU patients with 5 to 7 expected number of admission days
- patients with an expected Richmond Agitation Sedation Scale (RASS) of >-3 and < +3
- patients who speak Dutch (because of the qualitative evaluation of the Maya)
Exclusion Criteria:
- patients with severe brain damage
- patients with a severe psychiatric disorder
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group 1: Maya use on 1st, 3th and 5th day
Group 2: Maya use on the 2nd, 4th, and 6th day
Arm Description
Group 1 uses the Maya on the 1st, 3th and 5th day and not on the 2nd, 4th and 6th day of their admission to either the ICU, MC or CCU.
Group 2 uses the Maya on the 2nd, 4th and 6th day and not on the 1st, 3th, and 5th day of their admission to either the ICU, MC or CCU.
Outcomes
Primary Outcome Measures
Quality of sleep
patients' quality of sleep is measured once a day with the Richard Campbell Sleep Questionnaire (RCSQ); (minimum score 0 = worst sleep - maximum score 100 = best sleep)
Secondary Outcome Measures
NRS sleep
Patients' sleep is measured once a day with the sleep numeric rating scale (NRS sleep); (minimum score 0 = worst sleep - maximum score 10 = best sleep)
Anxiety
Patients' anxiety is measured once a day with the Daily Assesment of symptoms of Anxiety (DAS-A); (minimum score 0 = no anxiety - maximum score 24 = a lot of anxiety)
NRS Stress
Patients' stress is measured once a day with the stress numeric rating scale (NRS-stress); (minimum score 0 = no stress - maximum score 10 = most imaginable stress)
Arousal
patients' arousal is measured once a day with the Richmond Agitation Sedation Scale (RASS); (minimum score -5 = no reaction - maximum score = 4 very agitated)
Delirium CCU
CCU patients' delirium is measured once a day with the delirium observation scale (DOSS); (minimum score 0 = no delirium; a score of >= 3 means delirium; maximum score 65)
Delirium ICU/MC
ICU/MC patients' delirium is measured once a day with the Intensive Care Delirium Checklist (ICDSC); (minimum score 0 = no delirium; a score of 1 - 3 means subsyndromal delirium; a score of 4 - 8 means delirium; maximum score 8)
Light
Light level (LUX). This will be measured with a validated application on a mobile phone
Sound
Sound levels (decibel). This will be measured with a validated application on a mobile phone
Hart rate
hart rate is measured with a heart rate monitor and reported every two hours as beats per minute (BPM)
Respiratory rate
Respiratory rate is measured every two hours with a respiratory rate monitor and reported as rate per minute
oxygen saturation
Oxygen saturation is measured every two hours with a oxygen saturation monitor and reported as a percentage
Blood pressure
Blood pressure is measured every two hours with a intra-arterial catheter or a bloodpressure cuff and reported as diastolic value and systolic value (mmHg)
Full Information
NCT ID
NCT05078645
First Posted
September 13, 2021
Last Updated
October 4, 2021
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05078645
Brief Title
Improving Sleep and Reducing External Stimuli With the Maya
Official Title
Improving Sleep and Reducing External Stimuli With the Maya: a Pilot Study on Experience, Feasibility and Applicability
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Lack of sleep is a large problem for many patients in hospitals. Common causes are nuisances by light and sound. Especially with critically ill patients in the Intensive Care unit (ICU), Medium Care Unit (MCU) and Cardiac Care Unit (CCU), who are are monitored intensively, a lack of sleep often occurs.
Patients with a lack of sleep more offer suffer from delirium, are more often anxious and stressed, and have a longer length of stay in the hospital. Also, patients' lack of sleep enhances nurses workloads during nightshifts. Because of this, there is a strong need for innovative devices which aim to limit the light and sound nuisances and thereby enhance patients' quality of sleep in the ICU, MC and CCU.
The Maya is a special "cover" which can be placed over the head of the bed. As a result patients are able to limit light and sound nuisances and enhance their privacy.
With this pilot-study we aim to determine:
The feasibility and experiences of patients and healthcare professionals with the Maya.
To determine the effect size of dependent variables which can be used in future studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Pilot study with a crossover design. Half of the patients will use the Maya on the first, third and fifth day of their admission and will not use the maya on the second fourth and sixth day (group 1). The other half will use the Maya on the second, fourth and sixth day of their admission and will not use the maya on the first, third and fifth day (group 2). Group allocation will be randomised.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Maya use on 1st, 3th and 5th day
Arm Type
Other
Arm Description
Group 1 uses the Maya on the 1st, 3th and 5th day and not on the 2nd, 4th and 6th day of their admission to either the ICU, MC or CCU.
Arm Title
Group 2: Maya use on the 2nd, 4th, and 6th day
Arm Type
Other
Arm Description
Group 2 uses the Maya on the 2nd, 4th and 6th day and not on the 1st, 3th, and 5th day of their admission to either the ICU, MC or CCU.
Intervention Type
Device
Intervention Name(s)
Maya
Intervention Description
The Maya is a cover which can be placed over the end of the patients bed. The Maya aims to reduce light and sound nuisances and enhance patients' privacy
Primary Outcome Measure Information:
Title
Quality of sleep
Description
patients' quality of sleep is measured once a day with the Richard Campbell Sleep Questionnaire (RCSQ); (minimum score 0 = worst sleep - maximum score 100 = best sleep)
Time Frame
up to six days
Secondary Outcome Measure Information:
Title
NRS sleep
Description
Patients' sleep is measured once a day with the sleep numeric rating scale (NRS sleep); (minimum score 0 = worst sleep - maximum score 10 = best sleep)
Time Frame
up to six days
Title
Anxiety
Description
Patients' anxiety is measured once a day with the Daily Assesment of symptoms of Anxiety (DAS-A); (minimum score 0 = no anxiety - maximum score 24 = a lot of anxiety)
Time Frame
up to six days
Title
NRS Stress
Description
Patients' stress is measured once a day with the stress numeric rating scale (NRS-stress); (minimum score 0 = no stress - maximum score 10 = most imaginable stress)
Time Frame
up to six days
Title
Arousal
Description
patients' arousal is measured once a day with the Richmond Agitation Sedation Scale (RASS); (minimum score -5 = no reaction - maximum score = 4 very agitated)
Time Frame
up to six days
Title
Delirium CCU
Description
CCU patients' delirium is measured once a day with the delirium observation scale (DOSS); (minimum score 0 = no delirium; a score of >= 3 means delirium; maximum score 65)
Time Frame
up to six days
Title
Delirium ICU/MC
Description
ICU/MC patients' delirium is measured once a day with the Intensive Care Delirium Checklist (ICDSC); (minimum score 0 = no delirium; a score of 1 - 3 means subsyndromal delirium; a score of 4 - 8 means delirium; maximum score 8)
Time Frame
up to seven days
Title
Light
Description
Light level (LUX). This will be measured with a validated application on a mobile phone
Time Frame
up to six days
Title
Sound
Description
Sound levels (decibel). This will be measured with a validated application on a mobile phone
Time Frame
up to six days
Title
Hart rate
Description
hart rate is measured with a heart rate monitor and reported every two hours as beats per minute (BPM)
Time Frame
up to six days
Title
Respiratory rate
Description
Respiratory rate is measured every two hours with a respiratory rate monitor and reported as rate per minute
Time Frame
up to six days
Title
oxygen saturation
Description
Oxygen saturation is measured every two hours with a oxygen saturation monitor and reported as a percentage
Time Frame
up to six days
Title
Blood pressure
Description
Blood pressure is measured every two hours with a intra-arterial catheter or a bloodpressure cuff and reported as diastolic value and systolic value (mmHg)
Time Frame
up to six days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult ICU, MC or CCU patients with 5 to 7 expected number of admission days
patients with an expected Richmond Agitation Sedation Scale (RASS) of >-3 and < +3
patients who speak Dutch (because of the qualitative evaluation of the Maya)
Exclusion Criteria:
patients with severe brain damage
patients with a severe psychiatric disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bram Tilburgs, Dr.
Phone
0031 24 36155618
Email
bram.tilburgs@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Mark van den Boogaard, Dr.
Phone
0031 24 36155618
Email
mark.vandenboogaard@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bram Tilburgs, Dr.
Organizational Affiliation
adboudumc, intensive care, research
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Sleep and Reducing External Stimuli With the Maya
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